MAUDE Adverse Event Report: MAQUET SENSATION IAB CATHETER; INTRA AORTIC BALLOON CATHETER

Model Number 0684-00-0470-01U

Device Problems Deflation Problem (1149); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 12/29/2014

Event Type  Injury  

Event Description

A (b)(6) male needed a iabp catheter as an elective cv support until the patient had a capg the following day.All three iab catheters were inserted and acted the same say upon insertion.The catheters would begin to deflate on the distal portion of the catheter and would lose all inflation and wither.Three attempts were made w/three different catheters.This is the third catheter used.The datascope pumps were analyzed and found without defect.The catheters themselves were only suspect to have some type of defect.

• Brand Name: SENSATION IAB CATHETER
• Type of Device: INTRA AORTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET
• MDR Report Key: 4426143
• MDR Text Key: 5281531
• Report Number: MW5040218
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: 0684-00-0470-01U
• Device Lot Number: 3130
• Other Device ID Number: (01)106075567109558
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 85